PMA P240035S001

Device
ETHIZIA™ Hemostatic Patch
Applicant
ETHICON, Inc.
PMA number
P240035
Supplement
S001
Product code
SGV
Decision date
2026-01-22
Classification
General, Plastic Surgery
Generic name
Agent, absorbable hemostatic, collagen with polymeric additives
Approval order statement
a raw material supplier change for a gelatin carrier component in a hemostatic patch

Current openFDA PMA Record#

Device
ETHIZIA™ Hemostatic Patch
Applicant
ETHICON, Inc.
PMA number
P240035
Supplement
S001
Product code
SGV
Generic name
Agent, absorbable hemostatic, collagen with polymeric additives
Decision date
2026-01-22
Decision code
OK30
Date received
2025-12-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a raw material supplier change for a gelatin carrier component in a hemostatic patch